Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 28628 |
| Brand Name: | cobas 4800 HPV Test |
| Model: | |
| Affected: | KIT cobas 4800 HPV AMP/DET 240T CE-IVD M/N 05235901190; lot H05627. |
| Software version: | |
| Recalling Organisation: | Roche Diagnostics (NZ) Ltd 15 Rakino Way Mt Wellington AUCKLAND 1644 |
| Contact Information: | 0800 363 622 |
| Manufacturer: | Roche Diagnostics GmbH |
| Issue: | The manufacturer is requesting customers to discontinue the use of select cobas 4800 HPV Amplification/ Detection Kits and discard any remaining inventory immediately: KIT cobas 4800 HPV AMP/DET 240T CE-IVD M/N 05235901190; lot H05627. Internal quality data sources have demonstrated that the aforementioned kit lots may not be performing as intended and may result in invalid beta-globin signals for Positive Control (PC) replicates or patient samples. |
| Recall action type: | Recall |
| Recall action: | Product to be destroyed |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 19/11/2021 |
